Efficacy and safety of biodegradable polymer biolimus A9-eluting stent versus durable polymer everolimus-eluting stent in diabetic patients: a prospective non-randomized single-centre long-term comparison

Abstract

Objective Biodegradable polymer drug-eluting stents may improve biocompatibility and reduce the risk of very late stent thrombosis (ST) but outcomes are nevertheless unknown in diabetic patients. The purpose of this study was to assess the long-term efficacy and safety of the biodegradable polymer biolimus A9-eluting stent (BP-BES) in comparison with the current reference durable polymer everolimus-eluting stent (DP-EES) in diabetic patients.Methods and results 119 BP-BES and 178 DP-EES were implanted respectively in 105 and 146 diabetic patients presenting similar clinical and peri-procedural characteristics. The median follow-up time was 20.8 months. No statistically significant difference was observed between the BP-BES and DP-EES groups in terms of occurrence of the composite primary end point of cardiac death, spontaneous myocardial infarction and clinically indicated target lesion revascularization (8 patients [8%] in the BP-BES group versus 24 patients [17%] in the DP-EES group; HR 1.36, 95% CI 0.59-3.15, P = 0.47) and of the rate of ST (5 patients [5%] in the BP-BES group versus 11 patients [8%] in the DP-EES group; HR 0.73, 95% CI 0.22-2.37, P = 0.60).Conclusions In spite of a trend in favour of the BP-BES, long-term efficacy and safety were similar for both the BP-BES and the DP-EES in this specifi c population of diabetic patients. Considering the low incidence of the studied clinical events, other studies with larger population sizes are needed to confirm this observation.